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Cardiovascular DeconditioningSTAMASNCT02313142

Responses of the Cardiovascular Systems to Leg Exercises in Microgravity-like Conditions

A study testing Leg exercises in people with Cardiovascular Deconditioning, run by Swiss Federal Institute of Technology.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One of the major issues in space explorations is the negative effect of prolonged exposure to very low gravity (i.e. a condition often referred to as microgravity or weightlessness) on astronauts' health. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Deconditioning
What is being tested?
Leg exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jan 2015to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Signed informed consent

Who cannot join

  • Fracture lower extremities
  • Restricted range of motion in hip, knee or ankle joint which restricts standing or walking
  • Any injury limiting movements of the lower extremities
  • Pregnancy
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
  • Presence of any psychiatric condition
  • Tachycardia

About this study

One of the major issues in space explorations is the negative effect of prolonged exposure to very low gravity (i.e. a condition often referred to as microgravity or weightlessness) on astronauts' health. In this unusual condition the human body undergoes an adaptation process, often referred to as "deconditioning", that leads to significant loss of bone and muscle mass, hormonal changes, as well as modifications of important cardiovascular parameters. While the new physiological state is adequate to the microgravity environment, it results unsuitable upon return on earth. Hence after the mission astronauts experience various health-related problems and must undertake an intense rehabilitation program. Cardiovascular deconditioning originates mainly from a shift of blood from the lower extremities to the upper part of the body caused by the absence of gravity. In the long term (i.e. days) this causes a loss of blood and body fluid. In the short term (i.e. minutes) it elicits modifications to arterial blood pressure and heart rate.

In this study, funded by the European Union through the project STAMAS, we intend to evaluate whether leg physical exercises can lead to a displacement of blood towards the lower extremities, therefore ameliorating the upward fluid shift caused by weightlessness. More generally, we aim to investigate the short-term response of the cardiovascular system to leg exercises in microgravity-like conditions. After a clear understanding of these phenomena we will develop a controller that, by monitoring the physiological stare of a subject, will compute the appropriate exercise regime to stabilize his/her cardiovascular parameters to desired safe values. Our contribution will provide a better understanding of the cardiovascular system, and will delineate the physiological ground for the development of novel countermeasure devices against the cardiovascular deconditioning during space flight based on continuous leg exercises.

The protocol we propose in this document presents minimal risks for our potential subjects, while has the potential to produce important contributions. The cardiovascular parameters we intend to analyse are: blood pressure, heart rate and leg blood volume. These signals will be acquired non-invasively and with minimal risks. Leg exercises will be performed by means of a stepping device (MARCOS) previously developed in our Lab. MARCOS enables to vary the resistance applied against knee-extension movements, and therefore it allows a systematic evaluation of different exercise intensities. Finally, microgravity conditions can be easily emulated by letting the subjects lay on a tilted platform with head-down (i.e. head-down bed rest - HDBR, or head-down tilt - HDT) during the exercise sessions, thus inducing a shift of body fluid toward the thorax. The most effective inclination angle has proved to be as low as -6°, thus constituting only minimal risks for the subjects. In practice, subjects will comfortably lay on the negatively tilted platform and will perform stepping at different intensities while their cardiovascular parameters are being monitored and recorded in encrypted form for subsequent analysis.

Being tested
Leg exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leg exercisesBehavioural

Study groups in NCT02313142
Study groupRoleWhat they receive
SubjectsExperimentalNot described
Receives: Behavioral: Leg exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leg blood volume

    Measured: 110 min

Secondary outcomes (2)
  1. Heart-rate

    Measured: 110 min

  2. Blood pressure

    Measured: 110 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313142
Sponsor's protocol ID
STAMAS_v1.1_Nov2014
Acronym
STAMAS
Status last verified
Sep 2019
First submitted
5 Dec 2014
Last updated
18 Sep 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Leg exercises in people with Cardiovascular Deconditioning, run by Swiss Federal Institute of Technology.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leg blood volume (time frame: 110 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.

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